Visualization of HIFU-induced lesion boundaries by axial-shear strain elastography: a feasibility study

In this paper, we report on a study that investigated the feasibility of reliably visualizing high-intensity focused ultrasound (HIFU) lesion boundaries using axial-shear strain elastograms (ASSE). The HIFU-induced lesion cases used in the present work were selected from data acquired in a previous study. The samples consisted of excised canine livers with thermal lesions produced by a magnetic resonance-compatible HIFU system (GE Medical System, Milwaukee, WI, USA) and were cast in a gelatin block for the elastographic experiment. Both single and multiple HIFU-lesion samples were investigated. For each of the single-lesion samples, the lesion boundaries were determined independently from the axial strain elastogram (ASE) and ASSE at various iso-intensity contour thresholds (from -2 dB to -6 dB), and the area of the enclosed lesion was computed. For samples with multiple lesions, the corresponding ASSE was analyzed for identifying any unique axial-shear strain zones of interest. We further performed finite element modeling (FEM) of simple two-inclusion cases to verify whether the in vitro ASSE obtained were reasonable. The results show that the estimation of the lesion area using ASSE is less sensitive to iso-intensity threshold selection, making this method more robust compared with the ASE-based method. For multiple lesion cases, it was shown that ASSE enables high-contrast visualization of a “thin” untreated region in between multiple fully-treated HIFU-lesions. This contrast visualization was also noticed in the FEM predictions. In summary, the results demonstrate that it is feasible to reliably visualize HIFU lesion boundaries using ASSE. (E-mail: Arun.K.Thittai@uth.tmc.edu)     

Real-Time Monitoring of High-Intensity Focused Ultrasound Treatment Using Axial Strain and Axial-Shear Strain Elastograms

Axial strain elastograms (ASEs) have been found to help visualize sonographically invisible thermal lesions. However, in most studies involving high-intensity focused ultrasound (HIFU)-induced thermal lesions, elastography imaging was performed separately later, after the lesion was formed. In this article, the feasibility of monitoring, in real time, tissue elasticity variation during HIFU treatment and immediately thereafter is explored using quasi-static elastography. Further, in addition to ASEs, we also explore the use of simultaneously acquired axial-shear strain elastograms (ASSEs) for HIFU lesion visualization. Experiments were performed on commercial porcine liver samples in vitro. The HIFU experiments were conducted at two applied acoustic power settings, 35 and 20 W. The experimental setup allowed us to interrupt the HIFU pulse momentarily several different times during treatment to perform elastographic compression and data acquisition. At the end of the experiments, the samples were cut along the imaging plane and photographed to compare size and location of the formed lesion with those visualized on ASEs and ASSEs. Single-lesion and multiple-lesion experiments were performed to assess the contribution of ASEs and ASSEs to lesion visualization and treatment monitoring tasks. At both power settings, ASEs and ASSEs provided accurate location information during HIFU treatment. At the low-power setting case, ASEs and ASSEs provide accurate lesion size in real-time monitoring. Lesion appearance in ASEs and ASSEs was affected by the cavitation bubbles produced at the high-power setting. The results further indicate that the cavitation bubbles influence lesion appearance more in ASEs than in ASSEs. Both ASEs and ASSEs provided accurate size information after a waiting period that allowed the cavitation bubbles to disappear. The results indicate that ASSEs not only improve lesion visualization and size measurement of a single lesion, but, under certain conditions, also help to identify untreated gaps between adjacent lesions with high contrast.     

In vivo elastographic investigation of ethanol-induced hepatic lesions

Ethanol-induced hepatic lesions were investigated in swine for in vivo use as a strain imaging animal model. Lesions (n = 25) were induced by injecting ethanol (doses 0.33 to 2.0 mL) directly into the surgically exposed liver at depths of 12, 15 or 25 mm. Lesions were imaged with a modified HDI 1000 scanner (Philips Medical Systems, Bothell, WA, USA). The elastograms (n = 91) characterized lesions as being areas harder than the surrounding soft hepatic tissue. Elastographic lesion sizes and the corresponding injected ethanol dose used to induce the lesions were shown to be statistically significant (r(2) = 0.22; p = 0.029) using a linear regression analysis. Additionally, lesion depth was shown to be statistically insignificant (r(2) < 0.12; p > 0.10) when regressed against elastographic lesion size. An analysis of elastographic and gross pathology lesion sizes indicated no correlation (r(2) < 0.01; p = 0.973). Subsequently, lesion types were sorted by size and regression lines were computed from quasilinear regions of the corresponding run charts. Trend lines indicate a four-to-three size relationship between the selected elastographic and pathology lesion sizes. Comparison of elastogram lesion sizes from two independent observers using a paired t-test resulted in no statistically significant difference (p = 0.14). In conclusion, ethanol-induced hepatic lesions in swine is a suitable animal model for evaluation of strain-based imaging systems, due to the ease of generation and repeatability.     

Semiautomated thermal lesion segmentation for three-dimensional elastographic imaging

Several studies have demonstrated that lesion volumes computed from multiple planar slices through the region-of-interest (ROI) are more accurate than volumes estimated assuming simple shapes and incorporating single or orthogonal diameter estimates. However, manual delineation of boundaries on multiple planar 2-D images is tedious and labor-intensive. Automatic extraction of lesion boundaries is, therefore, attractive and imperative to remove subjectivity and reduce assessment time. This paper presents a semiautomated segmentation algorithm for thermal lesions on 3-D elastographic data to obtain both area and volume information. The semiautomated segmentation algorithm is based on thresholding and morphologic opening of both 2-D and 3-D elastographic data. Results obtained on 44 thermal lesions imaged in vitro using elastography were compared to manual delineation of both elastographic and pathology images. Results obtained using semiautomated segmentation demonstrate a close correspondence with manual delineation results. However, area and volume estimates obtained using both manual and semiautomated segmentation of lesions seen on elastograms slightly underestimate areas and volumes measured from pathology.     

Visualisation of HIFU lesions using elastography of the human prostate in vivo: preliminary results

An imaging system was developed for prostate elastography in vivo using a transrectal ultrasound (US) probe to guide high-intensity focused US (HIFU) therapy of prostate cancer. Uniform compression was applied using a balloon, while a sector image was acquired. Strain was calculated from the gradient of the displacements obtained from the ultrasonic signal using the cross-correlation technique. Elastograms were acquired on a total of 31 patients undergoing HIFU therapy for localised prostate cancer. For two patients, only part of the prostate was treated and posttherapy magnetic resonance imaging (MRI) confirmed the size and position of the HIFU lesions seen in the elastograms as low strain areas, with a strain contrast ratio between 1.6 and 3.2. The whole prostate was treated for the next 29 patients. After treatment, the whole prostate appeared to be stiff in the elastograms and a 40% to 60% (mean 50%) decrease in average strain was observed when compared to strains measured before HIFU application. Tumours identified by biopsies and sonograms could occasionally be seen in the preoperative elastograms. Decorrelation effects occurred mainly because of low sonographic signal-to-noise ratio (SNR) and of out-of-plane motion induced by respiration.     

Elastography for the follow-up of high-intensity focused ultrasound prostate cancer treatment: initial comparison with MRI

We previously developed an ultrasonic elastography imaging system that may provide a simple and cost-effective solution to monitor high-intensity focused ultrasound (HIFU) treatments. The objective of this clinical study was to evaluate the reliability of our system in assessing the volume of HIFU lesions in the prostate, using a comparison with magnetic resonance imaging (MRI). Elastograms were obtained in 20 patients after HIFU treatment for prostate cancer and gadolinium-enhanced T1- and T2-weighted MRI was performed. Lesion boundaries were manually outlined and the volume was calculated. A statistically significant correlation of rho = 0.62 (p = 0.022) was found between elastographic and MRI measurements of lesion volume, with elastographic measurements that generally underestimated the volume measured in MRI. Some basic physics (hypoechoic areas) and instrumentation (frame rate and band width) issues that were detrimental to image quality in vivo are reported, along with propositions to improve the technique. Because of these issues and, although good correspondence between elastographic and MRI measurements was found in some patients, elastographic measurements were unable to predict MRI measurements in a single individual. Nevertheless, the results confirmed the potential of elastography for monitoring HIFU treatment of the prostate. Further investigation will be conducted using better suited ultrasound equipment and performing real-time elastogram calculations.     

Impact of gas bubbles generated during interstitial ablation on elastographic depiction of in vitro thermal lesions.

OBJECTIVE: Artifacts from gas bubble formation during radio frequency ablation along with the poor intrinsic contrast between normal and treated regions (zone of necrosis) are considerable problems for the visualization of the necrotic region on conventional sonography. Sonographic elastography is very effective for visualizing the zone of necrosis, but it uses the same echo signals to estimate strain as those used to form gray scale images. Thus, the impact of gas bubbles on strain images or elastograms must be investigated. METHODS: Radio frequency ablation was performed in vitro on liver tissue samples, approximately 40 x 40 x 20 mm, encased in 80-mm cubed gelatin phantoms. Elastograms generated at different instants during the ablation procedures were obtained on a real-time scanner with a 5-MHz linear array. Sequences of elastograms illustrate the growth of the thermal lesion. RESULTS: Degradation of the distal boundary of the thermal lesion was observed. The degradation was confined to the lower-fifth quadrant of the thermal lesion. However, accurate estimates of lesion areas could still be obtained by extrapolation of the thermal lesion boundary. CONCLUSIONS: Elastograms of thermal lesions in vitro can be obtained during radio frequency ablation. Some loss of thermal lesion boundary information on strain images was observed in regions where attenuation due to gas bubbles reduced the signal-noise ratio of the echo signals.     

Improved visualization of high-intensity focused ultrasound lesions

Spectral parameter imaging in both the fundamental and harmonic of backscattered radio-frequency (RF) data were used for immediate visualization of high-intensity focused ultrasound (HIFU) lesion sites. A focused 5-MHz HIFU transducer with a coaxial 9-MHz focused single-element diagnostic transducer was used to create and scan lesions in chicken breast and freshly excised rabbit liver. B-mode images derived from the backscattered RF signal envelope were compared with midband fit (MBF) spectral parameter images in the fundamental (9-MHz) and harmonic (18-MHz) bands of the diagnostic probe. Images of HIFU-induced lesions derived from the MBF to the calibrated spectrum showed improved contrast (approximately 3 dB) of tumor margins versus surround compared with images produced from the conventional signal envelope. MBF parameter images produced from the harmonic band showed higher contrast in attenuated structures (core, shadow) compared with either the conventional envelope (3.3 dB core; 11.6 dB shadow) or MBF images of the fundamental band (4.4 dB core; 7.4 dB shadow). The gradient between the lesion and surround was 3.4 dB/mm, 6.9 dB/mm and 17.2 dB/mm for B-mode, MBF-fundamental mode and MBF-harmonic mode, respectively. Images of threshold and "popcorn" lesions produced in freshly excised rabbit liver were most easily visualized and boundaries best-defined using MBF-harmonic mode.     

Monitoring the formation of thermal lesions with heat-induced echo-strain imaging: a feasibility study

We investigated the feasibility of using echo-strain images to visualize the extent of high-intensity ultrasound (US)-induced thermal lesions during their formation. Echo-strain, defined as the relative deformation of the backscattered ultrasonic signal, is due to tissue expansion and to changes in the speed of sound during heating. First, a theoretical framework was developed to predict the influence of these effects on the echo signal. Then, a simulation tool was developed to create simulated echo-strain images in thermal lesions. Finally, experimental echo-strain images were acquired in 10 porcine liver samples in vitro for various exposure durations and ultrasonic intensities (resulting in lesions that extended 3 to 8 mm deep from the surface). For this purpose, radiofrequency (RF) frames were acquired at 8 frames per s while heating. For each consecutive pair of RF frames, an echo-strain image was calculated using standard elastographic processing. The echo-strain images were cumulated and displayed. The experimental echo-strain images were compared with gross pathology. The (isoechoic) lesions were visible both in simulated and in experimental cumulated echo-strain images as apparent expansion areas (tensile echo-strain), whereas surrounding tissues exhibited apparent compression. The tensile echo-strain area underestimated the lesion in simulations, but was representative of the lesion in experiments. High correspondence was found between the lesion depth measured from experimental cumulative echo-strain images (y) and from gross pathology (x) (Pearson's correlation = 0.90, linear regression y = x-0.1 mm, residual error = 0 +/- 0.9 mm). We hypothesized that significant tissue expansion made the thermal lesions highly visible in the experimental echo-strain images. In two cases, the ultrasonic intensity was too low to induce a lesion, and the corresponding experimental echo-strain images showed no visible lesion. We conclude that cumulative echo-strain images have the potential to monitor the formation of high-intensity US-induced thermal lesions.     

Segmentation of elastographic images using a coarse-to-fine active contour model

Delineation of radiofrequency-ablation-induced coagulation (thermal lesion) boundaries is an important clinical problem that is not well addressed by conventional imaging modalities. Elastography, which produces images of the local strain after small, externally applied compressions, can be used for visualization of thermal coagulations. This paper presents an automated segmentation approach for thermal coagulations on 3-D elastographic data to obtain both area and volume information rapidly. The approach consists of a coarse-to-fine method for active contour initialization and a gradient vector flow, active contour model for deformable contour optimization with the help of prior knowledge of the geometry of general thermal coagulations. The performance of the algorithm has been shown to be comparable to manual delineation of coagulations on elastograms by medical physicists (r = 0.99 for volumes of 36 radiofrequency-induced coagulations). Furthermore, the automatic algorithm applied to elastograms yielded results that agreed with manual delineation of coagulations on pathology images (r = 0.96 for the same 36 lesions). This algorithm has also been successfully applied on in vivo elastograms.     

Three-dimensional electrode displacement elastography using the Siemens C7F2 fourSight four-dimensional ultrasound transducer

Because ablation therapy alters the elastic modulus of tissues, emerging strain imaging methods may enable clinicians for the first time to have readily available, cost-effective, real-time guidance to identify the location and boundaries of thermal lesions. Electrode displacement elastography is a method of strain imaging tailored specifically to ultrasound-guided electrode-based ablative therapies (e.g., radio-frequency ablation). Here tissue deformation is achieved by applying minute perturbations to the unconstrained end of the treatment electrode, resulting in localized motion around the end of the electrode embedded in tissue. In this article, we present a method for three-dimensional (3D) elastographic reconstruction from volumetric data acquired using the C7F2 fourSight four-dimensional ultrasound transducer, provided by Siemens Medical Solutions USA, Inc. (Issaquah, WA, USA). Lesion reconstruction is demonstrated for a spherical inclusion centered in a tissue-mimicking phantom, which simulates a thermal lesion embedded in a normal tissue background. Elastographic reconstruction is also performed for a thermal lesion created in vitro in canine liver using radio-frequency ablation. Postprocessing is done on the acquired raw radio-frequency data to form surface-rendered 3D elastograms of the inclusion. Elastographic volume estimates of the inclusion compare reasonably well with the actual known inclusion volume, with 3D electrode displacement elastography slightly underestimating the true inclusion volume.     

Elastographic image quality vs. tissue motion in vivo

Elastography is a noninvasive method of imaging tissue elasticity using standard ultrasound equipment. In conventional elastography, axial strain elastograms are generated by cross-correlating pre- and postcompression digitized radio frequency (RF) echo frames acquired from the tissue before and after a small uniaxial compression, respectively. The time elapsed between the pre- and the postcompression frames is referred to as the interframe interval. For in vivo elastography, the interframe interval is critical because uncontrolled physiologic motion such as heartbeat, muscle motion, respiration and blood flow introduce interframe decorrelation that reduces the quality of elastograms. To obtain a measure of this decorrelation, in vivo experimental data (from human livers and thyroids) at various interframe intervals were obtained from 20 healthy subjects. To further examine the effect of the different interframe intervals on the elastographic image quality, the experimental data were also used in combination with elastographic simulation data. The deterioration of elastographic image quality was objectively evaluated by computing the area under the strain filter (SF) at a given resolution. The experimental results of this study demonstrate a statistical exponential behavior of the temporal decay of the echo signal cross-correlation amplitudes from the in vivo tissues due to uncontrollable motion. The results also indicate that the dynamic range and height of the SF are reduced at increased interframe intervals, suggesting that good objective image quality may be achieved provided only that a high frame rate is maintained in elastographic applications.     

Elastographic imaging of the normal canine prostate in vitro

Elastography has been shown to be successful in mapping the relative mechanical attributes of normal as well as abnormal tissues. In this study, the histological characteristics of freshly excised normal canine prostates were used to explain consistently depicted elastographic features. The elastograms of the transverse cross-sections across the urethra demonstrated a consistent symmetry of the gland as well as clear anatomic structures. These include a central portion of the gland surrounding the urethra and a peripheral gland. The central gland was consistently softer than the peripheral gland. At the level of the verumontanum, depicted as a small stiff ridge, the lumen of the urethra was consistently demonstrated as an inverted soft 'u' or 'v' shaped area. The network of branching-fibrous connective tissue septa was depicted by the elastogram as linear features, which converged on the urethra. In the anterior side of the gland, the fibromuscular stroma was seen as a circumscribed hard tissue. In the sagittal view, the elastogram suggested a stiff peripheral zone surrounding a softer central zone, which is traversed by the urethra depicted as soft tissue.     

A quantitative comparison of modulus images obtained using nanoindentation with strain elastograms

Tissue stiffness is generally known to be associated with pathologic changes. Ultrasound (US) elastography, on the other hand, is capable of imaging tissue strain, which may or may not be well-correlated with tissue stiffness. Hence, a quantitative comparison between the elastographic tissue strain images and the corresponding tissue modulus images needed to be performed to evaluate the usefulness of elastography in imaging tissue stiffnesss properties. Simulations were performed to demonstrate and quantify the similarities between modulus images and strain elastograms. This was followed by comparing nanoindenter-based modulus images with strain elastograms of thin slices of tissue-mimicking phantoms. Finally, some beef slices, canine prostates, ovine kidneys and breast cancers grown in mice were used to demonstrate the qualitative correspondence between modulus images and strain elastograms. The simulations and the experiments indicated that it is feasible to perform quantitative comparisons between strain images (using elastography) and modulus images on certain tissue structures and geometries. A good quantitative correspondence (correlation values of greater than 0.8) between structures in the modulus and strain images could be obtained at scales equal to or larger than 20 Qlambda (where Q is the quality factor defined as the ratio of the center frequency over the band width and lambda is the wavelength of the US system) modulus contrasts larger than 5, applied strains between 0.5% and 3% and window lengths for computing strain elastograms between 3 Qlambda and 5 Qlambda. The gelatin-phantom experiments showed lower values of correlation (values around 0.5) than with theory and simulations. The decrease in correlation was attributed to the presence of measurement noise in both strain elastography and modulus imaging, an increase of dimensionality of the problem (from 2-D to 3-D), local anisotropy, heterogeneity and nonstationarity. Experiments on real tissue slices showed further decrease in the correlation to around 0.3, possibly due to additional confounding factors such as time-dependent mechanical properties and geometrical distortions in the tissue during imaging. The work presented in this paper demonstrates that there is an intrinsic relationship between strain elastograms and the actual distribution of soft tissue elastic moduli, and bodes well for continued work in the area of elastography.     

Radiation-force technique to monitor lesions during ultrasonic therapy

This report describes a monitoring technique for high-intensity focused ultrasound (US), or HIFU, lesions, including protein-denaturing lesions (PDLs) and those made for noninvasive cardiac therapy and tumor treatment in the eye, liver and other organs. Designed to sense the increased stiffness of a HIFU lesion, this technique uniquely utilizes the radiation force of the therapeutic US beam as an elastographic push to detect relative stiffness changes. Feasibility was demonstrated with computer simulations (treating acoustically induced displacements, concomitant heating, and US displacement-estimation algorithms) and pilot in vitro experimental studies, which agree qualitatively in differentiating HIFU lesions from normal tissue. Detectable motion can be induced by a single 5 ms push with temperatures well below those needed to form a lesion. Conversely, because the characteristic heat diffusion time is much longer than the characteristic relaxation time following a push, properly timed multiple therapy pulses will form lesions while providing precise control during therapy.     

Comparative evaluation of strain-based and model-based modulus elastography

Elastography based on strain imaging currently endures mechanical artefacts and limited contrast transfer efficiency. Solving the inverse elasticity problem (IEP) should obviate these difficulties; however, this approach to elastography is often fraught with problems because of the ill-posed nature of the IEP. The aim of the present study was to determine how the quality of modulus elastograms computed by solving the IEP compared with those produced using standard strain imaging methodology. Strain-based modulus elastograms (i.e., modulus elastograms computed by simply inverting strain elastograms based on the assumption of stress uniformity) and model-based modulus elastograms (i.e., modulus elastograms computed by solving the IEP) were computed from a common cohort of simulated and gelatin-based phantoms that contained inclusions of varying size and modulus contrast. The ensuing elastograms were evaluated by employing the contrast-to-noise ratio (CNR(e)) and the contrast transfer efficiency (CTE(e)) performance metrics. The results demonstrated that, at a fixed spatial resolution, the CNR(e) of strain-based modulus elastograms was statistically equivalent to those computed by solving the IEP. At low modulus contrast, the CTE(e) of both elastographic imaging approaches was comparable; however, at high modulus, the CTE(e) of model-based modulus elastograms was superior.     

Freehand ultrasound elastography of breast lesions: clinical results.

We developed a freehand method for ultrasound elastography, which can be applied during a routine sonographic examination with off-line calculation of strain images (elastograms). Forty-eight patients with 53 breast lesions were examined and, after biopsy or operation, histologic reports were available for all lesions. The correlation coefficient of time delay estimates was used as a quality criterion for the subsequent calculation of elastograms. Beyond the qualitative evaluation of elastograms, we suggested a semiquantitative approach. For that purpose, the elastogram of each lesion was normalized to an overall strain of 1% (i.e., the average strain in the image was set to 1%). After normalization, we determined mean strain values inside and outside of each lesion, respectively. Defining solid lesions as benign and malignant lesions except for fibrous mastopathy, we found significant difference in strain between solid lesions and their surrounding tissue. However, that result must not be misunderstood to suggest that it was possible to distinguish benign from malignant lesions in general. Still, we address the potential of ultrasound elastography to improve the detection and localization of breast lesions as well as their differential diagnosis. Besides, we developed a freehand applicator for further studies, which guarantees a homogeneous axial compression regardless of the experience of the examiner.     

Tradeoffs in elastographic imaging

This paper presents the tradeoffs in elastographic imaging. Elastography is viewed as a new imaging modality and presented in terms of three fundamental concepts that constitute the basis for the elastographic imaging process. These are the tissue elastic deformation process, the statistical analysis of strain estimation and the image characterization. The first concept involves the use of the contrast transfer efficiency (CTE) that describes the mapping of a distribution of local tissue elastic moduli into a distribution of local longitudinal tissue strains. The second concept defines the elastographic system and the relationship between ultrasonic and signal processing parameters. This process is described in terms of a stochastic framework (the strain filter) that provides upper and practical performance bounds and their dependence on the various system parameters. Finally, the output image, the elastogram, is characterized by its image parameters, such as signal-to-noise ratio, contrast-to-noise ratio, dynamic range and resolution. Finite-element simulations are used to generate examples of elastograms that are confirmed by the theoretical prediction tools.     

Effects of ultrasonic exposure parameters on myocardial lesions induced by high-intensity focused ultrasound.

OBJECTIVE: This study evaluated variables relevant to creating myocardial lesions using high-intensity focused ultrasound (HIFU). Without an effective means of tracking heart motion, lesion formation in the moving ventricle can be accomplished by intermittent delivery of HIFU energy synchronized by electrocardiographic triggering. In anticipation of future clinical applications, multiple lesions were created by brief HIFU pulses in calf myocardial tissue ex vivo. METHODS: Experiments used f-number 1.1 spherical cap HIFU transducers operating near 5 MHz with in situ spatial average intensities of 13 and 7.4 kW/cm2 at corresponding depths of 10 and 25 mm in the tissue. The distance from the HIFU transducer to the tissue surface was measured with a 7.5-MHz A-mode transducer coaxial and confocal with the HIFU transducer. After exposures, fresh, unstained tissue was dissected to measure visible lesion length and width. Lesion dimensions were plotted as functions of pulse parameters, cardiac structure, tissue temperature, and focal depth. RESULTS: Lesion size in ex vivo tissue depended strongly on the total exposure time but did not depend strongly on pulse duration. Lesion width depended strongly on the pulse-to-pulse interval, and lesion width and length depended strongly on the initial tissue temperature. CONCLUSIONS: High-intensity focused ultrasound creates well-demarcated lesions in ex vivo cardiac muscle without damaging intervening or distal tissue. These initial studies suggest that HIFU offers an effective, noninvasive method for ablating myocardial tissues to treat several important cardiac diseases.     

Utility of a tumor-mimic model for the evaluation of the accuracy of HIFU treatments. results of in vitro experiments in the liver

Presented in this article is a tumor-mimic model that allows the evaluation, before clinical trials, of the targeting accuracy of a high intensity focused ultrasound (HIFU) device for the treatment of the liver. The tumor-mimic models are made by injecting a warm solution that polymerizes in hepatic tissue and forms a 1 cm discrete lesion that is detectable by ultrasound imaging and gross pathology. First, the acoustical characteristics of the tumor-mimics model were measured in order to determine if this model could be used as a target for the evaluation of the accuracy of HIFU treatments without modifying HIFU lesions in terms of size, shape and homogeneity. On average (n = 10), the attenuation was 0.39 +/- 0.05 dB.cm(-1) at 1 MHz, the ultrasound propagation velocity was 1523 +/- 1 m.s(-1) and the acoustic impedance was 1.84 +/- 0.00 MRayls. Next, the tumor-mimic models were used in vitro in order to verify, at a preclinical stage, that lesions created by HIFU devices guided by ultrasound imaging are properly positioned in tissues. The HIFU device used in this study is a 256-element phased-array toroid transducer working at a frequency of 3 MHz with an integrated ultrasound imaging probe working at a frequency of 7.5 MHz. An initial series of in vitro experiments has shown that there is no significant difference in the dimensions of the HIFU lesions created in the liver with or without tumor-mimic models (p = 0.3049 and p = 0.8796 for the diameter and depth, respectively). A second in vitro study showed that HIFU treatments performed on five tumor-mimics with safety margins of at least 1 mm were properly positioned. The margins obtained were on average 9.3 +/- 2.7 mm (min. 3.0 - max. 20.0 mm). This article presents in vitro evidence that these tumor-mimics are identifiable by ultrasound imaging, they do not modify the geometry of HIFU lesions and, thus, they constitute a viable model of tumor-mimics indicated for HIFU therapy.